@article{ART002601128},
author={Sujung Yoo and Seulbi Choi and Eun-Ae Kim},
title={Necessity and directions of changing approach to vulnerability in research involving humans},
journal={Journal of the Korea Bioethics Association},
issn={1598-0324},
year={2020},
volume={21},
number={1},
pages={1-24},
doi={10.37305/JKBA.2020.06.21.1.1}
TY - JOUR
AU - Sujung Yoo
AU - Seulbi Choi
AU - Eun-Ae Kim
TI - Necessity and directions of changing approach to vulnerability in research involving humans
JO - Journal of the Korea Bioethics Association
PY - 2020
VL - 21
IS - 1
PB - The Korean Bioethics Association
SP - 1
EP - 24
SN - 1598-0324
AB - To protect the vulnerable individuals and groups (thereafter referred to as "vulnerable subjects") is an important concern in research involving human subjects such as clinical trials. The responsibility for protecting the vulnerable subjects lies with researchers and the Institutional Review Boards (thereafter referred to as the "IRBs"). In order for researchers and IRBs to protect the vulnerable subjects, they must be able to answer what the vulnerability is as well as to identify who the vulnerable subjects are. However, under the current law such as 「Bioethics and Safety Act」 and Pharmaceutical Affairs Act」, the definition of vulnerable subjects focuses more on grouping and listing those who should be considered vulnerable. Therefore, there is a lack of clear identifying criteria or methods to determine the vulnerability and the vulnerable subjects, or to accurately and flexibly identify the vulnerable subjects for each research involving human subjects and to come up with practical protection measures for them. In addition, the conventional definition and traditional approach to the vulnerability can be criticized because it involves categorical exclusion of all members of a group that have a certain characteristic. Accordingly, this approach marginalizes the vulnerable subjects, rather than protects them. In this context, this article analyzes the problems of the conventional approach to the vulnerability and the concerns related to the definition of vulnerable subjects. This article also discusses the ways to modify the legal definition of vulnerable subjects and existing approach to the vulnerability. This article analyze the contents of the Helsinki Declaration, the Belmont Report, and the International ethical guidelines for health-related research involving humans 2016 by the CIOMS. Based on the results of this analysis, we argue that the legal definition of vulnerable subjects should be presented appropriately in identifying the vulnerable subjects in research involving human subjects as a higher concept. Furthermore, we also argue that the vulnerability should be amended to understand why attention should be paid to the vulnerable subjects. Finally, we argue that the vulnerability and the vulnerable subjects should be judged not only by considering various types of vulnerability but also by comprehensively considering the overall context surrounding the research and the research subjects, and the reasons for participating as well as the reasons for excluding vulnerable subjects should also be considered.
KW - Vulnerability;Vulnerable Subjects;CIOMS Guideline;Declaration of Helsinki;Bioethics and Safety Act;Institutional Review Board
DO - 10.37305/JKBA.2020.06.21.1.1
ER -
Sujung Yoo, Seulbi Choi and Eun-Ae Kim. (2020). Necessity and directions of changing approach to vulnerability in research involving humans. Journal of the Korea Bioethics Association, 21(1), 1-24.
Sujung Yoo, Seulbi Choi and Eun-Ae Kim. 2020, "Necessity and directions of changing approach to vulnerability in research involving humans", Journal of the Korea Bioethics Association, vol.21, no.1 pp.1-24. Available from: doi:10.37305/JKBA.2020.06.21.1.1
Sujung Yoo, Seulbi Choi, Eun-Ae Kim "Necessity and directions of changing approach to vulnerability in research involving humans" Journal of the Korea Bioethics Association 21.1 pp.1-24 (2020) : 1.
Sujung Yoo, Seulbi Choi, Eun-Ae Kim. Necessity and directions of changing approach to vulnerability in research involving humans. 2020; 21(1), 1-24. Available from: doi:10.37305/JKBA.2020.06.21.1.1
Sujung Yoo, Seulbi Choi and Eun-Ae Kim. "Necessity and directions of changing approach to vulnerability in research involving humans" Journal of the Korea Bioethics Association 21, no.1 (2020) : 1-24.doi: 10.37305/JKBA.2020.06.21.1.1
Sujung Yoo; Seulbi Choi; Eun-Ae Kim. Necessity and directions of changing approach to vulnerability in research involving humans. Journal of the Korea Bioethics Association, 21(1), 1-24. doi: 10.37305/JKBA.2020.06.21.1.1
Sujung Yoo; Seulbi Choi; Eun-Ae Kim. Necessity and directions of changing approach to vulnerability in research involving humans. Journal of the Korea Bioethics Association. 2020; 21(1) 1-24. doi: 10.37305/JKBA.2020.06.21.1.1
Sujung Yoo, Seulbi Choi, Eun-Ae Kim. Necessity and directions of changing approach to vulnerability in research involving humans. 2020; 21(1), 1-24. Available from: doi:10.37305/JKBA.2020.06.21.1.1
Sujung Yoo, Seulbi Choi and Eun-Ae Kim. "Necessity and directions of changing approach to vulnerability in research involving humans" Journal of the Korea Bioethics Association 21, no.1 (2020) : 1-24.doi: 10.37305/JKBA.2020.06.21.1.1